Perphenazine

Product NDC: 70518-4688
Requested package NDC: 70518-4688-0
11-digit product format: 705184688
Labeler code: 70518
Product ID: 70518-4688_558bfb3b-a3ea-a4b0-e063-6394a90a70de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Perphenazine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA089685
Marketing category: ANDA
Marketing start: 2026-07-01
Marketing end: 2027-03-21
Substance: PERPHENAZINE
Active strength: 2 mg/1
Pharmacologic classes: Phenothiazine [EPC]; Phenothiazines [CS]
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089685-001	PERPHENAZINE	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08
A089685-002	PERPHENAZINE	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08
A089685-003	PERPHENAZINE	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08
A089685-004	PERPHENAZINE	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A089685-001	AB
A089685-002	AB
A089685-003	AB
A089685-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A089685-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089685-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089685-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089685-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Perphenazine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PERPHENAZINE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FTA7XXY4EZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198076	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
da5519cd-7b96-4468-910c-87dffdb1888e	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	9588d223-41e4-4bb2-9306-f082498404c5	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	da5519cd-7b96-4468-910c-87dffdb1888e	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685 ndc (package): 70518-4688-0 ndc (product): 70518-4688 ndc11 (package): 70518468800
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	fc903628-248c-4d12-88b4-a551aeadb4d2	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685
Perphenazine	PERPHENAZINE	Sandoz Inc	fc32500c-cc42-4f85-9cee-88f983fcbc16	2024-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FTA7XXY4EZ	PERPHENAZINE	58-39-9	PERPHENAZINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Status
70518-4688-0	70518468800	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4688-0)	2026-07-01	2027-03-21	0	Historical